Revised Appendices A & B Update

Jeff J. Sindelar, Ph.D.University of Wisconsin

Topics for Discussion

• Review & background of Appendices A & B thermal processing and stabilization guidelines

• Revised Appendices A & B documents • Changes in revised versions• Responses from stakeholders

Review & Background of USDA, FSIS Appendices A & B

USDA, FSIS Appendix A• Compliance Guidelines For Meeting Lethality

Performance Standards For Certain Meat And Poultry Products --- January 1999• Based upon research by Goodfellow and Brown (1978)• Conducted in 3rd party research facility (ABC Research

Laboratories)• Supported (contracted) by industry • Accepted by government (utilized “USDA-approved

protocol)

USDA, FSIS Appendix A Components

• Lethality (internal)• Time/temperature

tables

USDA, FSIS Appendix A Components

• Relative humidity requirement• With exceptions (i.e.

casing, size)

“Heating roasts of any size to a minimum internal temperature of 145 °F (62.8 °C) in an oven maintained at any temperature if the relative humidity of the oven is maintained either by continuously introducing steam for 50 percent of the cooking time or by use of a sealed oven for over 50 percent of the cooking time, or if the relative humidity of the oven is maintained at 90 percent or above for at least 25 percent of the total cooking time, but in no case less than 1 hour; or…”

USDA, FSIS Appendix A Components

• Slow come-up time• “Dwell times of greater than 6

hours in the 50°F to 130°F range should be viewed as especially hazardous, as this temperature range can foster substantial growth of many pathogens of concern”

Goodfellow & Brown Experimental Design

1. D-value generation• 1 gram inoculated meat samples placed in test-tubes

immersed in water baths at 125, 135, and 145°F

2. Validation• Dialysis tubing technique • Temperature collection• Beef rounds• Water cooked (165°F)

Goodfellow & Brown Experimental Design

1. IT= 125°F2. IT= 125°F for 1 hour3. IT= 125°F for 3 hours4. IT= 125°F for 5 hours5. IT= 125°F for 7 hours6. IT= 130°F7. IT= 130°F for 10 minutes8. IT= 130°F for 30 minutes9. IT= 130°F for 1 hour

10. IT= 130°F for 2 hours11. IT= 135°F12. IT= 135°F for 3 minutes13. IT= 135°F for 6 minutes14. IT= 135°F for 10 minutes15. IT= 135°F for 20 minutes16. IT= 140°F17. IT= 145°F

Goodfellow & Brown Experimental Design

3. Surface lethality• Dry roasting experiments

• Surface inoculated with Salmonella • Commercial kitchen oven (Frigidaire) at 200, 225, and 275°F• Sampling when surface temperature reached 125, 130, and 135°F

• Mixed steam injected-dry roasting experiments• Single truck batch oven (Vortron)• TRT 1: steam injected during first 30 minutes• TRT 2: steam injected the last 30 minutes• Product temperature collected• Surface samples collected when internal temperature reached 120,

125, 130, and 135°F

Goodfellow & Brown D-Value Results

• D-value generation• Thermal death curves were

developed • Z-values generated

Goodfellow & Brown Validation Results

• Validation (internal)• 125°F was marginal (survivors after 7 hours)• 130°F = 7-log reduction if held between 30 and 60 minutes• 135°F = 7-log reduction if held 3 minutes• 140 and 145°F = instantaneous 7-log reduction• Integrated lethality added margin of safety• Thermal processing table created as requested by USDA, FSIS

Goodfellow & Brown Surface Lethality Results

• Dry roasting experiments• Confirmed USDA preliminary data of 175°F roasting was

not sufficient • Relative humidity (RH) was 0.02%• Postulated survival was a result of rapid dehydration creating heat

resistance

• Concluded surface lethality could be achieved if 1) oven and internal finished product temperatures were high enough and 2) product size was large enough

• Higher roasting and internal temperatures showed increased efficacy

Goodfellow & Brown Surface Lethality Results

• Mixed steam injected-dry roasting experiments• Injection of steam for >30 minutes eliminated Salmonella

• The point in process wasn’t significantly different• Attributed to the “injection of steam”

• A “very high humidity level” experiment was found to be very effective

• Level was not measured

USDA, FSIS Appendix B

• Compliance Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization) --- January 1999• USDA, FSIS has provide guidance for controlling Clostridium

perfringens since 1985• Very low (and sporadic) occurrence of illness from products

produced in inspected facilities• Very little science and heavy use of baseline data collection

and statistical evaluation• No more than 1-log growth increase allowed during cooling

USDA, FSIS Appendix B

• How 1-log10 was established – the approach• > 6 log10 C. perfringen levels are needed to cause illness• CDC considers viable counts of 5 log10 C. perfringens for

incriminating a food• USDA, FSIS Microbiological survey data suggested

approximately 4 log10/gram is present on meat/poultry• If cooling results in 1 log10 growth, there could be a small

percentage of samples with > 5 log10 of C. perfringens• Applying a 1-log theoretical growth (to reach 6 log10)

established a “no more than 1-log10 growth” parameter

USDA, FSIS Appendix B

• How 1-log10 was established – potential flaws• Data was collected on raw samples and applied to

cooked products• Baseline studies did not differentiate between vegetative

cells and spores• The microbiological method did not provide

confirmation of C. perfringens• The actual number of C. perfringens on the raw samples was not

known.

• An overestimation likely occurred resulting in very conservative cooling parameters

Updated Compliance Guidelines for Cooking (Appendix A) and

Cooling (Appendix B)

• Docket No. FSIS–2017–0016- Salmonella Compliance Guidelines for Small and Very Small Meat and Poultry Establishments that Produce Ready-to-Eat (RTE) Products and Revised Appendix A --- June 2017

• FSIS Compliance Guideline f or Stabilization (Cooling and Hot-Holding) of Fully and Partially Heat-Treated RTE and NRTE Meat and Poultry Products Produced by Small and Very Small Establishments and Revised Appendix B --- June 2017

Revised Appendix A

• Notable changes• “When heating meat or poultry products of any size when the

cooking time is less than 1 hour to any internal temperature and time combinations in Appendix A, the Poultry Time-Temperature Tables, and the 5-log table the Relative humidity of the oven is maintained at 90 percent for the entire cooking time.”

• Relative humidity requirements only applicable to semi-permeable or impermeable casings

Impingement Oven Example (HansonTech, 2018)

DryBulb

WetBulb

Core

Surface

Buffalo wings cooked in an impingement oven High-temperature impingment process Relative humidity < 5.0%

HansonTech LLC Jan-2017 500 480 460 440 420 400 380 360 340 320 300 280 260 240 220 200 180 160 140 120 100

80 60 40 20

0 1 2 3 4 5 6 7 8 9

time (minutes)

Process < 1 hour & <90% RH (5% actual)

Revised Appendix B• Notable changes

• Option 2: 120°F to 80°F < 1.0 hours & 80°F to 40°F in < 5.0 hours

• Replaced 120°F to 55°F < 6.0 hours• Thermodynamically impossibly to achieve for many products

thicker than 4.5 inches

• Partially cooked products must be cooled using Option 1 (130°F to 80°F < 1.5 hours & 80°F to 40°F in < 4.0 hours)

• Products containing a minimum of 100 ppm sodium nitrite and 250 ppm ascorbate or erythorbate (regardless of source) can be chilled using the following parameters:

• 130°F to 80°F < 5.0 hours & 80°F to 40°F in < 10.0 hours

Cooling data for non-cured roast beefHansonTech 09-Nov-2016

180

170

160

150

140

130

120

110

100

90

80

70

60

50

40

30

20

10

0

-10

-208 9 10 11 12 13

14 15 16 17

time (hr)

Tem

pera

ture

(F)

AirTopCenter

AirBottomCorner

CoreFront

CoreBack

CoreBottomCorner

Non-cured Roast Beef Example (HansonTech, 2018)

Cooling Times 130 to 80oF 120 to 80oF

Appendix B, new Actual cooling time

1.5 hr2.58 hr

1.0 hr1.95 hr

Observations: This product fails both Options 1 and 2. Cooler temperature was 0 to -10oF, which cooled the product as fast as thermodynamically possible. A brand new chiller will not cool it any faster. The new FSIS requirements for Options 1 and 2 are thermodynamically impossible for this product.

Appendices A & B Implementation

• Updated Appendix A & B released June 2017

• Comment period Fall of 2017

• Delay implementation announced March 2018• FSIS Notice 17-18• New implementation date of March 2019• USDA, FSIS agreed to meet with non-industry experts to

discuss 2017 versions of Appendix A & B

Responses from Stakeholders

Formation of NAMI Appendices A & B Working Group

• Organized group during Spring 2018

• Composed of • Core working group members (academic scientists &

consultants)• Industry advisory group (food safety & regulatory experts)• Association partners

• Purpose: • Review the revised version of Appendices A and B along

with the issues identified in the industry and help determine possible solutions.

Core Working Group Members

• Jonathan Campbell – Pennsylvania State University • Jim Dickson – Iowa State University • Kerri Gehring – Texas A & M University • Kathy Glass – University of Wisconsin-Madison • Bob Hanson – HansonTech• Dana Hanson – North Carolina State University • Margaret Hardin – IEH Laboratories • John Henson – California State University-Fresno • Andy Milkowski – University of Wisconsin-Madison • Jeff Sindelar – University of Wisconsin-Madison • Peter Taormina – Etna Consulting Group• Bruce Tompkin – Retired/Consultant

Industry Advisory Group

• Aaron Asmus – Hormel• Larry Epling – Case Farms • Dan Etzler – Cargill• Alison Griffino – Tyson Foods• Nancy Gushing – Ok Foods • Barry Hays – Bar S• Jeremiah Johnson – Hormel • Kristin Lindahl – Cargill • Tina Rendon – Pilgrims

Association Partners

• Jonathan Campbell – Eastern State Meat Packers• Joe Harris – Southwest Meat Association• Lisa Picard – National Turkey Federation• Ashley Peterson – National Chicken Council• KatieRose McCullough – North American Meat Institute• Rafael Rivera – US Poultry and Egg• Kristen Spotz – Grocery Manufacturers Association• Jessica Watson – National Cattleman’s Beef Association • Chris Young – American Association of Meat Processors

NAMI Appendices A&B Working Group Activity

• First meeting (conference call) on May 11, 2018

• Several conference calls/emails/correspondences

• Review/discussion of historic and current regulatory and scientific documentation

• Electronic file sharing system established

• Participated in USDA, FSIS / Working Group meeting• July 30, 2018

NAMI Foundation for Meat and Poultry Research and Education

“mini grants”• Three funded (January 31, 2019 final reports due)

1. Effects of Product Moisture and Process Humidity on Pathogen Lethality during Continuous Cooking of Meat and Poultry Products

2. Validating growth models for Clostridium perfringens, Clostridium botulinum, and Bacillus cereus during cooling of uncured meat and poultry products

3. Development and Validation of Dynamic Predictive Models for Growth and Toxin Formation by Staphylococcus aureus in Low Temperature Cooked Products

7/30 Meeting Attendees• Jonathan Campbell – Pennsylvania State University/Eastern

State Meat Packers• Bob Hanson – Hanson Tech Consulting • Kathy Glass – University of Wisconsin• Jeff Sindelar – University of Wisconsin • Bruce Tompkin – Retired/Consultant • Andy Milkowski – University of Wisconsin • Aaron Asmus – Hormel• Alison Griffino – Tyson• Barry Hays – Bar S• Dan Etzler – Cargill• Kristin Lindahl – Cargill • Ashley Peterson – National Chicken Council• Nelson Gaydos – American Association of Meat Processors• Joe Harris – Southwest Meat Association• KatieRose McCullough – North American Meat Institute• Kristen Spotz – Grocery Manufacturers Association• Lisa Picard – National Turkey Federation

• Roberta Wagner – FSIS • Bill Shaw – FSIS • Anna Porto-Fett – ARS• John Luchansky – ARS• Denise Eblen – FSIS• Evelyne Mbandi – FSIS • Johnathan Huang – FSIS• Jude Smedra – FSIS • Kevin Dutch – FSIS • Kis Robertson – FSIS • Kristina Barlow – FSIS • Meryl Silverman – FSIS • Michael Updike – FSIS • Rachel Edelstein – FSIS • Sharon Costley – FSIS • Susan Hammonds – FSIS • Tim Mohr – FSIS • Udit Minocha – FSIS

USDA, FSIS Identified Scientific Gaps & Possible Solutions• Some products can’t meeting cooling limits in

Appendix B• Options 1-4: As listed in 2017 Stabilization Guideline• Option 5: Any pH; 130°F to 80°F in 2 h; to 40 °F ≤ 7 h total• Option 6: Any pH; 126°F to 80°F in 1.75 h; to 55 °F ≤ 6 h total• Option 7: pH ≤6.0; 126°F to 80°F in 2.25 h; to 55 °F ≤ 6 h total• Option 8: pH ≤5.8; 126°F to 80°F in 2.75 h; to 55 °F ≤ 6 h total• Option 9: Partially cooked products CUT ≤ 3 hour + 2% salt + 150 ppm nitrite

+ erythorbate; to 40 °F ≤ 6.5 h total

• Physiochemical e.g. (pH, salt, etc.) impact on cooling• Computer modeling

USDA, FSIS Open Research Gaps

• Support for short-time, high-temperature cooking• Validated methods to measure moisture and• Validated temperature, time, and moisture parameters.

• Support for lethality treatments for baked goods cooked with raw meat and poultry components where relative humidity in the cooking environment is not desired.

• Support for the conditions that impact when and how natural casings begin maintaining sufficient moisture to ensure product lethality using FSIS time and temperature tables without addressing relative humidity.

• Support for extended come-up and come-down time for partially heat treated smoked products other than bacon (e.g., hams and sausages) and identification of the active constituents in liquid smoke and natural smoke.

Working Group Identified Scientific Gaps & Possible Solutions for

Appendix A

Desiccated Salmonella (HansonTech, 2018)

FSIS Appendix A (2017) — Humidity Options

If IT > 145oF and cooking time > 60 minutes, then —Option 1.

Option 2.

Steam injection for 50% of time, or 1 hr

Sealed oven capable of maintaining humidity level for 50% of time, or 1 hr

Humidity > 90% for 25% of time, or 1 hrOption 3.

If IT < 145oF and cooking time > 60 minutes, then —

Option 4. Maintain humidity > 90% for 25% of time, or 1 hr

If cooking time < 60 minutes, then —

Option 5. Maintain humidity > 90% for the entire time

Preventing desiccation

Appendix A: Situations where humidity is not needed

1. Water or steam cook

2.Impermeable bag

3.Direct contact or flame heat

4.Impermeable or semi-permeable casing

5.Beef patties

The Problem: Heat Tolerance ofDesiccated Pathogens (HansonTech, 2018)

Effect of desiccation on heat tolerance of Salmonella entericaAverage numbers of cells that survived exposure to 140, 176, or 212oF for 60 minutes

(adapted from Gruzdev et al, 2011)

9

8

7

6

3

2

1

0

4

5

140 176

Temperature (oF)

212

Log

surv

iver

s(1

0x )

Non-desiccated Rehydrated Desiccated

No detectable survivors

Chicken tenders (3% fat) cooked in impingement oven -- Surface Lethality Step(adapted from Sindelar et al, 2016)

0

150

100

50

200

250

400

350

300

450

0 1 2time (minutes)

3 4

Tem

pera

ture

(F) DryBulb

WetBulb

Core

Surface

Surface Lethality Step (SLS)

Zone 1 Zone 2 (SLS step)

Surface was dehydrated early in process.

Surface was not re-hydrated in SLS step.

Survivors = 3.4 logs

Roasted chicken wings cooked in JSO impingement ovenHansonTech 10-Jan-2018

500480460440420400380360340320300280260240220200180160140120100

806040200

0 1 2 3 4 5 6

time (minutes)7 8 9 10 11 12

Tem

pera

ture

(F)

DryBulb

WetBulb

Core

Surface

Option 5: If cooking time is less than 1 hr, RH must be 90% for entire cook

Process: RH = 2% (PsyCalc)

Flaws in Appendix A: Impingement Cooking (HansonTech, 2018)

Possible Solutions: Defining the Problem

• Two requirements to assure surface lethality:• Heat the surface to a lethal time-temperature combination• Surface must be hydrated during the lethal time-temperature

period

• How can you tell if the surface is hydrated?• During steam cooking, the surface will be hydrated• During dry cooking, you can compare the surface

temperature to the wet-bulb temperature to tell if the surface is wet or dry

• If the surface is hydrated, the wet bulb temperature remains at (or higher) than the surface temperature

Netted hams cooked in forced-air smokehousePre-smoked-nets, 5.1" diameter, football-shape

2001901801701601501401301201101009080706050403020100

0 1 2 3time (hours)

4 5 6

Tem

pera

ture

(F)

DryBulb

WetBulb

Core

Surface

Smokehouse: Steam CookLethality Step (HansonTech, 2018)

Steam Cook Lethality Step• 50 minutes @ 178oF steam

Roasted chicken wings cooked in JSO impingement ovenHansonTech 10-Jan-2018

500480460440420400380360340320300280260240220200180160140120100

806040200

0 1 2 3 4 5 6

time (minutes)7 8 9 10 11 12

Tem

pera

ture

(F)

DryBulb

WetBulb

Core

Surface

HSL time = 3.5 minutes

Impingement: Hydrated SurfaceLethality Step (HansonTech, 2018)

Hydrated Surface Lethality Time = 3.5 min

HSL option: The surface temperature achieved 158oF before exceeding the wet-bulb temperature.

If IT > 145oF and cooking time > 60 minutes, then —Option 1.

Option 2.

Steam injection for 50% of time, or 1 hr

Sealed oven capable of maintaining humidity level for 50% of time, or 1 hr

Humidity > 90% for 25% of time, or 1 hrOption 3.

Option X. Use steam-cook lethality step where the steam temperature is maintained for the time-temperatures listed in Appendix A.

Option Y. Use a hydrated-surface lethality step where the surface temperature is maintained at the time-temperatures listed in Appendix A without exceeding the wet-bulb temperature.

Steam Cook Lethality Step

Hydrated Surface Lethality Step

Alternative Ideas (Proposed)

Working Group Identified Scientific Gaps & Possible Solutions for

Appendix B

Compilation of Cooling Times for Large Non-cured Meat and

Poultry ProductsCooling Times

Product 130 to 80oF Appendix BDome breast 3.03 h 1.5 hPan breast 2.2 hRoast beef 2.25 hRoast beef 1.8 hRoast beef 2.6 hDome breast(Marlen)

1.9 h

Dome breast(Marlen)

2.9 h

Whole tom turkeys

1.82 h

• The rate of chilling required to meet new guidelines is thermodynamically impossible for large products

• Is limitation for 1-log growth an appropriate andnecessary target?

• Will millions of dollars of chiller upgrades advance foodsafety?

• For many products, upgraded chillers will still not meetthe new compliance guidelines

• For small and very small, the cost will be too high, sowhole product categories will have to be eliminated

Appendix B Talking Points

Working Group / USDA, FSIS Action Steps

• Follow Up Letters• Association • Core Working Group

• Additional engagement/working meetings (suggested)• Appendix A – Surface lethality and casing • Appendix B – Extended cooling of large diameter products, C.

perfringens baseline, partially heat treated items. • Bacillus cereus • Presentation of research projects – 3 Recently Funded and the

Slow Come Up Time Work (ISU/UW) • Final presentation of suggestions

Working Group / USDA, FSIS Action Steps

• Clostridium perfringens baseline study• Identify appropriate methodology• Collect baseline data from industry establishments willing to

share

• Continued conference calls (every 2-3 weeks)

• Proposed additional delay of implementation (if needed)

Questions?